Skip to main content
OpenTrials
Completed

NCT Number: NCT05530499

Effects of Almonds on Immune Health and Responsiveness

This study has the primary objective of investigating the benefits of consuming whole almonds on immune health and immune response in adults with obesity.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diet Intervention

Age range

30 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Missouri-Columbia

Columbia, Missouri, 65211, United States

About this study

The study is a six week, randomized, controlled, and parallel arm clinical trial in which participants will be randomized to consume either 57 grams of whole almonds daily or to consume an isocaloric cookie snack daily. Outcomes assessed will include blood and adipose immune markers, cardiometabolic biomarkers, and gut microbiome.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body mass index (BMI): 30-45 kg/m^2
  • Willingness to consume study foods
  • Willing to comply with study protocol
  • Consistent diet and activity patterns for 4 weeks
  • Weight stable (no greater than 5 kg change over the last 3 months)
  • Non-smoker > 1 year or more

Exclusion criteria

  • Regular consumer of nuts
  • Planning on getting viral vaccines during study
  • Allergies to study foods (almonds, cookies)
  • Illicit drug use
  • Recent start of medications that affect metabolism or appetite
  • Current use of medication that interfere with immune measures
  • Diabetes
  • Drug therapy for coronary artery disease, peripheral artery disease, congestive heart failure, or dyslipidemia
  • Pregnant of lactating individuals
  • Lidocaine allergies

Treatment and study plan

Almond supplementation

Other

Daily consumption of 57g of whole almonds

Cookie supplementation

Other

Daily consumption of cookie snack calorically equivalent to 57 grams of whole almonds.

Primary outcomes

  1. Change in immune and inflammatory markers

    Time frame: Over 6 weeks

    Lymphocytes, granulocytes, monocytes, interleukins, cytokines, etc.

  2. Change in immune cell profile

    Time frame: Over 6 weeks

    Immunophenotyping

Secondary outcomes

  1. Body mass

    Time frame: Baseline, week 3, and week 6

    Measured in kg

  2. Body composition

    Time frame: Baseline, week 3, and week 6

    Fat mass and fat-free mass

  3. Anthropometrics

    Time frame: Baseline, week 3, and week 6

    Waist circumference, hip circumference, thigh circumference

  4. Glucoregulation

    Time frame: Baseline and week 6

    Fasting glucose concentrations

  5. Insulinemic biomarker concentrations

    Time frame: Baseline and week 6

    Fasting insulin and C-peptide concentrations

  6. Lipid profile

    Time frame: Baseline and week 6

    LDL, HDL, triglycerides, total cholesterol

  7. Blood pressure

    Time frame: Baseline, week 3, week 6

    Diastolic and systolic blood pressure

  8. Dietary intake

    Time frame: Baseline, week 1, week 2, week 3, week 4, week 5, week 6

    24 hours dietary recall and food frequency questionnaires

  9. 24 hour appetite ratings

    Time frame: Baseline, week 6

    24 hour appetite rating survey

  10. Physical activity

    Time frame: Baseline, week 6

    Activity assessment using Actigraphs

  11. Sleep

    Time frame: Baseline, week 6

    Sleep monitors and questionnaires

  12. Transcriptomics profiles

    Time frame: Baseline, week 6

    RNAseq

  13. Palatability rating of foods

    Time frame: Baseline, week 3, week 6

    Hedonic general labelled magnitude scale (gLMS)

  14. Acceptance rating of foods

    Time frame: Baseline, week 3, week 6

    9-point food action rating scale

Other outcomes

  1. Gut microbiome profile

    Time frame: Baseline, week 6

    16S rRNA sequencing

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Collaborators

  • Almond Board of California

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 7, 2022
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.